PURPOSE: To determine the effect and safety of verteporfin therapy (Visudyne) in Japanese age-related macular degeneration (AMD) patients. DESIGN: Open-label, multicenter, prospective, noncontrolled study. METHODS: The setting was five university hospitals in Japan. The study population was patients at least 50 years old, with best-corrected visual acuity of 20/40 to 20/200 inclusive and fluorescein angiography documenting subfoveal, classic-containing choroidal neovascularization (CNV) secondary to AMD and a lesion of greatest linear dimension <or= 5400 microm. For the intervention, patients received verteporfin intravenously followed by light administration 15 minutes after the infusion start. Additional treatment was given every 3 months through month 9 if leakage from CNV was observed on angiogram. The main outcome measure was percentage of lesions with progression of classic CNV beyond the area of the baseline lesion. RESULTS: Sixty-four patients were enrolled at five centers, and 61 patients completed the study. The median number of treatments given during the trial was three. At the 12-month examination, 12 patients (19%; 95% confidence interval: 11%-31%) had progression of classic CNV whereas 32 (50%) and 49 (77%) patients had no leakage from classic or occult CNV, respectively. The median visual acuity score (approximate Snellen equivalent) from baseline to month 12 increased from 50.0 (20/100)-56.5 (20/80(+2)) letters. Fourteen patients (22%) had visual disturbances, including two patients (3%) with acute vision decrease considered as serious adverse events and one patient (2%) with infusion-related back pain. No photosensitivity reactions were reported. CONCLUSIONS: Verteporfin therapy for subfoveal CNV in these Japanese patients appeared to have a similar or better angiographic and vision effect as that observed in Caucasian patients, with the same safety profile, supporting its use in Japanese patients.
PURPOSE: To determine the effect and safety of verteporfin therapy (Visudyne) in Japanese age-related macular degeneration (AMD) patients. DESIGN: Open-label, multicenter, prospective, noncontrolled study. METHODS: The setting was five university hospitals in Japan. The study population was patients at least 50 years old, with best-corrected visual acuity of 20/40 to 20/200 inclusive and fluorescein angiography documenting subfoveal, classic-containing choroidal neovascularization (CNV) secondary to AMD and a lesion of greatest linear dimension <or= 5400 microm. For the intervention, patients received verteporfin intravenously followed by light administration 15 minutes after the infusion start. Additional treatment was given every 3 months through month 9 if leakage from CNV was observed on angiogram. The main outcome measure was percentage of lesions with progression of classic CNV beyond the area of the baseline lesion. RESULTS: Sixty-four patients were enrolled at five centers, and 61 patients completed the study. The median number of treatments given during the trial was three. At the 12-month examination, 12 patients (19%; 95% confidence interval: 11%-31%) had progression of classic CNV whereas 32 (50%) and 49 (77%) patients had no leakage from classic or occult CNV, respectively. The median visual acuity score (approximate Snellen equivalent) from baseline to month 12 increased from 50.0 (20/100)-56.5 (20/80(+2)) letters. Fourteen patients (22%) had visual disturbances, including two patients (3%) with acute vision decrease considered as serious adverse events and one patient (2%) with infusion-related back pain. No photosensitivity reactions were reported. CONCLUSIONS:Verteporfin therapy for subfoveal CNV in these Japanese patients appeared to have a similar or better angiographic and vision effect as that observed in Caucasian patients, with the same safety profile, supporting its use in Japanese patients.